Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Phase 4CompletedNCT02208843

Boehringer Ingelheim60 enrolled

Overview

The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

AfatinibDRUG

Afatinib tablet once daily until progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology. 2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation. 3. Measureable disease according to RECIST 1.1. 4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen. 5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. 6. Adequate organ function. Exclusion criteria: 1. More than one line of prior therapy for disease. 2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment. 3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody. 4. Known pre-existing interstitial lung disease.

Locations (21)

Clinical Research Center, Alexandria University Hospital

Alexandria, Egypt

Outcomes

Primary Outcomes

Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1

As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions

Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Secondary Outcomes

Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.

Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.

Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1

As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Data from ClinicalTrials.gov

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